ADAKVEO (crizanlizumab-tmca) · Novartis
Adakveo (crizanlizumab-tmca) is a selectin blocker indicated to reduce the frequency of vaso-occlusive crises in patients with sickle cell disease. The therapy is approved for use in adults and pediatric patients aged 16 years and older. It serves a therapeutic role by targeting the underlying cellular adhesion processes that contribute to these complications.
How ADAKVEO Works
Crizanlizumab-tmca is a humanized monoclonal antibody that binds to P-selectin and blocks its interaction with ligands such as P-selectin glycoprotein ligand 1. By binding to P-selectin on the surface of activated platelets and endothelial cells, the drug prevents these cells from interacting with red blood cells and leukocytes. It can also dissociate preformed complexes between P-selectin and its ligands. This inhibition of cellular adhesion helps manage the biological interactions that lead to vaso-occlusive crises.
Details
- Status
- Prescription
- First Approved
- 2019-11-15
- Patent Cliff
- 2026
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ADAKVEO Approval History
What ADAKVEO Treats
1 indicationsADAKVEO is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Sickle Cell Disease
ADAKVEO Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
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Trial Timeline
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ADAKVEO FDA Label Details
Indications & Usage
FDA Label (PDF)ADAKVEO ® is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease. ADAKVEO is a selectin blocker indicated to reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.